Crystallisation
Crystallization is a critical step in drug substance manufacturing, influencing key process outcomes such as impurity control, yield, throughput, filtration and drying performance, solid form control, and regulatory compliance (e.g., particle size). It also plays a vital role in downstream processing, affecting properties such as flowability, bulk density, and dissolution behaviour.
At Asymchem Sandwich, we leverage our world-class expertise, extensive experience, and state-of-the-art equipment to develop robust and scalable crystallization processes tailored to client and project needs. Our approach ensures seamless scale-up from laboratory development to commercial manufacturing while maintaining process consistency and efficiency. We focus on all aspects of the crystallization process to enhance both process robustness and downstream performance.
Through our capabilities, Asymchem Sandwich ensures the development of scalable, high-quality crystallization processes that meet both regulatory requirements and commercial manufacturing needs.
Crystallisation Core Capabilities
- Solubility screening and metastable zone width (MSZW) determination to optimize supersaturation control and mitigate uncontrolled nucleation.
- Comprehensive crystallization process development and optimization, focusing on yield maximization, impurity rejection, and solid form stability.
- Solid form selection and control, including the identification and optimization of polymorphs, hydrates, solvates, and co-crystals to meet regulatory and performance criteria.
- Understanding and scaling up hydrodynamics to ensure efficient mixing, heat transfer, and mass transfer across scales.
- In-situ process analytical technology (PAT) tools, including Blaze Metrics, EasySampler, ReactIR, and FBRM, enabling real-time monitoring of nucleation, growth kinetics, and particle attributes.
- Particle size distribution measurement and control strategies to enhance filtration, drying, and flow properties, ensuring batch-to-batch consistency.
- Data-driven approaches for predictive modelling and optimization of crystallization parameters.
- Regulatory-compliant process design, ensuring alignment with ICH guidelines, impurity control strategies, and cGMP manufacturing standards.
